Remote Senior Medical Writer - Regulatory Docs Lead

transperfect; Princeton (NJ); Remote; USD 110,000 - 160,000; Full time

Job summary

TransPerfect seeks an organized, motivated senior medical writer to join our medical writing team. You will partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents for drug development under tight timelines.

The role emphasizes lead document development, cross-functional coordination, and expert use of document management tools.

Qualifications

• Five+ years of medical writing experience in CRO/biotech/pharmaceutical fields.
• Experience writing regulatory documents (protocols, study reports, etc.).
• Familiarity with ICH and US regulatory requirements.

Responsibilities

• Lead the execution of documents and manage timelines.
• Coordinate cross-functional client contributors and internal resources.
• Ensure documents adhere to client processes and templates.
• Lead kickoff meetings and manage review feedback.
• Maintain consistency across messaging, formatting, and presentation of documents.

Skills

Medical writing

Cross-functional collaboration

Project management

Communication skills

Attention to detail

Education

Bachelor's degree

Tools

Microsoft Word

Document management systems

Job description

TransPerfect seeks an organized, motivated senior medical writer to join our medical writing team. You will partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents for drug development under tight timelines.

The role emphasizes lead document development, cross-functional coordination, and expert use of document management tools.